We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Educational-Medical-Behavioral Treatment of Fecal Incontinence (FIX)

This study has been terminated.
(Low enrollment led sponsor to terminate study early.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717456
First Posted: October 30, 2012
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
William (Bill) Whitehead, PhD, University of North Carolina, Chapel Hill
Results First Submitted: May 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fecal Incontinence
Interventions: Other: Education
Dietary Supplement: Fiber supplements
Drug: Laxatives or anti-diarrheals
Behavioral: Pelvic floor muscle exercises
Behavioral: Tips on how to prevent fecal incontinence
Behavioral: Daily diary
Other: Protective pads or garments

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Home Health Care (HHC) provided lists to the investigators of new patients who were screened by HHC using the OASIS Questionnaire. Research assistants identified eligible patients based on the OASIS questions and telephoned them to obtain verbal consent and to schedule a baseline assessment visit. Written consent was obtained at the baseline visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Baseline data collection and written consent was obtained at a home visit prior to referring the patient to HHC for randomization and initiation of treatment. Only 19/31 who gave consent to the research assistant were randomized. 3 others were judged ineligible by HHC, and 9 dropped out while awaiting treatment.

Reporting Groups
  Description
Educational-Medical-Behavioral Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
Standard Care Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].

Participant Flow for 2 periods

Period 1:   End of Treatment
    Educational-Medical-Behavioral   Standard Care
STARTED   11   8 
COMPLETED   11   6 
NOT COMPLETED   0   2 
Physician Decision                0                1 
Lost to Follow-up                0                1 

Period 2:   Follow-Up 6 Months After End of Tx
    Educational-Medical-Behavioral   Standard Care
STARTED   11   6 
COMPLETED   7   2 
NOT COMPLETED   4   4 
Lost to Follow-up                4                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population is limited to patients who were randomized after referral to Home Health Care.

Reporting Groups
  Description
Educational-Medical-Behavioral Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
Standard Care Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
Total Total of all reporting groups

Baseline Measures
   Educational-Medical-Behavioral   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   8   19 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   86.11  (4.51)   85.00  (3.61)   85.83  (4.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
Female      11 100.0%      5  62.5%      16  84.2% 
Male      0   0.0%      3  37.5%      3  15.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   9.1%      0   0.0%      1   5.3% 
White      10  90.9%      3  37.5%      13  68.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      5  62.5%      5  26.3% 
Fecal Incontinence Severity Index (FISI) at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   24.50  (12.22)   22.75  (8.14)   23.72  (2.44) 
[1] Subjects rated the frequency of 4 types of stool leakage (gas, mucus, liquid, and solid) over the prior month on a 6-stepscale. Possible responses were never, 1-3 times/ month, once/week, 2 or more times/week, once/day, and 2 or more times/day. Based on the average quality of life impact scores assigned by a reference group of 34 subjects with fecal incontinence, weights were assigned to each of these 4 responses and added together for a sum score. Range is 0-61. No guidance on what defines mild, moderate, or severe is available. Higher scores show more severe fecal incontinence.
Manchester Health Questionnaire (MHQ) Severity Scale at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   48.64  (17.76)   50.00  (18.13)   49.21  (17.42) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. The range of scores of each domain is 0-100, and higher scores indicate greater impairment. Means and SDs for a reference group of 154 FI patients were published.
MHQ Incontinence Impact at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   52.27  (23.60)   65.63  (26.52)   57.89  (25.07) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Role Limitations at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   13.64  (26.49)   50.00  (29.12)   28.95  (32.56) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Physical Limitations at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   18.18  (21.91)   50.00  (28.35)   31.58  (28.98) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Social Limitations at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   16.67  (29.11)   43.75  (35.57)   28.07  (33.93) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Personal Relationships at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   8.33  (20.41)   20.00  (32.60)   13.64  (25.89) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Emotions at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   19.70  (15.49)   51.04  (28.67)   32.89  (26.57) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
MHQ Sleep Energy at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   7.95  (14.00)   23.44  (28.69)   14.47  (22.15) 
[1] The MHQ (Br J Obstetrics & Gynecol 2001;108:1057-67) is a 32-item questionnaire that assesses the impact of anal incontinence on quality of life in women. Each item is answered on a 5-point ordinal scale. Eight of 9 subscales were used: incontinence impact, role, physical function, social function, personal function, emotional problems, sleep/energy, and severity. A total score was calculated by summing the subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Zarit Caregiver Burden Scale at Baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   36.00  (42.43)   18.33  (13.50)   22.75  (14.13) 
[1] The Zarit Caregiver Burden Interview is a 22-item questionnaire to assess the perceived burden of taking care of another ill or physically impaired person. All items are answered on a 5-step ordinal scale (from never to nearly always). Higher scores depict greater burden on the family. The total score range is from 0 to 66.
Frequency of fecal incontinence at Baseline [1] [2] 
[Units: Units on a scale]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 9   2   11 
   2 
 (1 to 5) 
 4.5 
 (4 to 5) 
 2 
 (1 to 5) 
[1]

OASIS question M1620. 6-level ordinal scale.

0 = Never or rarely incontinent for stool

  1. = Less than 1/week
  2. = 1-3 days/week
  3. = 4-6 days/week
  4. = Daily stool leakage
  5. = Multiple times per day

Higher scores represent worse outcomes.

Data were missing for 2/11 in Group A and for 6/8 in Group B.

[2] Data were missing for 2/11 in Group A and 6/8 in Group B.
Urinary Continence Status at Baseline [1] [2] 
[Units: Units on a scale]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 9   2   11 
   1 
 (0 to 1) 
 0.5 
 (0 to 1) 
 1 
 (0 to 1) 
[1]

OASIS Question M1610 is a 3-level ordinal scale.

0 = No urinary incontinence

  1. = Incontinence for urine
  2. = Patient requires catheter

Data are missing for 2/11 in Group A and 6/8 in Group B. Having a catheter is equivalent to having urinary incontinence; therefore, the investigators treated a 2 as equivalent to a 1.

[2] Data were missing for 2/11 in Group A and 6/8 for Group B.
Cognitive Function at Baseline [1] [2] 
[Units: Units on a scale]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 9   2   11 
   0 
 (0 to 0) 
 0 
 (0 to 0) 
 0 
 (0 to 0) 
[1]

OASIS Question M1700. 5-level ordinal scale:

0 = Alert and oriented

  1. = Requires prompting for unfamiliar activities
  2. = Requires assistance when task demands shifting attention
  3. = Requires assistance for routine tasks
  4. = Totally dependent

Data missing for 2/11 in Group A and 6/8 in Group B. A higher number indicates a greater degree of cognitive impairment.

[2] Data were missing for 2/11 in Group A and 6/8 for Group B.
Ambulation at Baseline [1] 
[Units: Units on a scale]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   0 
 (0 to 2) 
 0.5 
 (0 to 1) 
 0.2 
 (0 to 2) 
[1]

OASIS Question M1860 is a 7-level ordinal scale.

0 = Walks without assistance

  1. = Uses cane or other one-hand assistive device
  2. = Uses walker or other two-hand assistive device
  3. = Able to walk with assistance
  4. = Chair-fast but can wheel self around
  5. = Chair-fast and requires assistance
  6. = Bedfast

Higher scores indicate a greater degree of physical impairment.

Ability to use toilet at Baseline [1] [2] 
[Units: Participants]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 9   2   11 
   0 
 (0 to 0) 
 0 
 (0 to 0) 
 0 
 (0 to 0) 
[1]

OASIS Question M1840 is a 5 level ordinal scale. Steps are:

0 = Independent self-toileting

  1. = Uses toilet when reminded to do so
  2. = Unable to reach toilet but can use a bedside commode
  3. = Limited to use of a bedpan
  4. = Totally dependent in toileting

Missing data for 2/11 in Group A and 6/8 in Group B.

Higher scores indicate a greater degree of impairment in toileting behavior.

[2] Data were missing for 2/11 in Group A and 6/8 for Group B.
When is patient anxious at Baseline? [1] 
[Units: Units on a scale]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 11   8   19 
   0 
 (0 to 0) 
 0 
 (0 to 0) 
 0 
 (0 to 0) 
[1]

OASIS Question M1720 is a 4-level ordinal scale. Responses are:

0 = Never

  1. = Less than every day
  2. = Daily but not constantly
  3. = All the time

Higher scores indicate a greater level of anxiousness.

Depression Screening at Baseline [1] 
[Units: Participants]
     
Not screened for depression       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Not screened for depression   8   1   9 
Screened by Patient Health Questionnaire 2 (PHQ2)       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Screened by Patient Health Questionnaire 2 (PHQ2)   1   1   2 
Requires further evaluation       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Requires further evaluation   0   0   0 
Screened and does not need further evaluation       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Screened and does not need further evaluation   0   0   0 
Unknown       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Unknown   2   6   8 
[1]

OASIS Question M1730 has 4 discrete categories. Possible responses are:

0 = Patient was not screened for depression

  1. = Screened by PHQ2 depression scale
  2. = Meets criteria for further screening for depression
  3. = Does not meet criteria for further screening

Higher scores indicate a greater level of depression.

Living Situation at Baseline [1] 
[Units: Participants]
     
Lives alone       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Lives alone   3   0   3 
Lives with another adult       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Lives with another adult   4   2   6 
Lives in assisted living       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Lives in assisted living   2   0   2 
Unknown       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Unknown   2   6   8 
[1]

OASIS Question M1100 has 3 discrete categories which are:

1 = Lives alone 6 = Lives with another person 11 = Lives in assisted living

Scores are labels describing the patient's living situation.

Source of Assistance with ADLs at Baseline [1] 
[Units: Participants]
     
No assistance needed       
Participants Analyzed 
[Units: Participants]
 11   8   19 
No assistance needed   5   2   7 
Caregiver provides assistance       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Caregiver provides assistance   3   0   3 
Caregiver needs training or support       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Caregiver needs training or support   0   0   0 
Caregiver unlikely to provide assistance       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Caregiver unlikely to provide assistance   0   0   0 
Unclear if caregiver will assist patient       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Unclear if caregiver will assist patient   0   0   0 
Assistance needed but not available       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Assistance needed but not available   0   0   0 
Unknown       
Participants Analyzed 
[Units: Participants]
 11   8   19 
Unknown   3   6   9 
[1]

OASIS Question M2100 has 5 discrete categories which are:

0 = No assistance needed

  1. = Caregiver provides assistance for activities of daily living (ADLs)
  2. = Caregiver needs training or support
  3. = Caregiver is not likely to provide assistance
  4. = Unclear if caregiver will provide assistance
  5. = Assistance needed but none is available

Higher scores indicate a greater need for assistance with ADLs.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fecal Incontinence Severity Index (FISI) at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

2.  Primary:   Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)   [ Time Frame: 6 months after (6-Week) treatment ends ]

3.  Secondary:   Adequate Relief of Fecal Incontinence at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

4.  Secondary:   Adequate Relief of Fecal Incontinence at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

5.  Secondary:   MHQ Severity Scale at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

6.  Secondary:   MHQ Severity Scale at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

7.  Secondary:   Zarit Caregiver Burden Scale at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

8.  Secondary:   Zarit Caregiver Burden Scale at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

9.  Secondary:   Fecal Incontinence Frequency at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

10.  Secondary:   Urinary Incontinence Status Change From Baseline to End of Treatment   [ Time Frame: Baseline, end of treatment (week 6) ]

11.  Secondary:   Admission to Nursing Home at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

12.  Secondary:   MHQ Incontinence Impact at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

13.  Secondary:   MHQ Incontinence Impact at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

14.  Secondary:   MHQ Role Limitations at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

15.  Secondary:   MHQ Role Limitations at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

16.  Secondary:   MHQ Physical Limitations at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

17.  Secondary:   MHQ Physical Limitations at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

18.  Secondary:   MHQ Social Limitations at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

19.  Secondary:   MHQ Social Limitations at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

20.  Secondary:   MHQ Personal Relationships at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

21.  Secondary:   MHQ Personal Relationships at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

22.  Secondary:   MHQ Emotions at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

23.  Secondary:   MHQ Emotions at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

24.  Secondary:   MHQ Sleep Energy at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

25.  Secondary:   MHQ Sleep Energy at Follow Up   [ Time Frame: 6 months after (6-Week) treatment ends ]

26.  Other Pre-specified:   Cognitive Status at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

27.  Other Pre-specified:   Change in Ambulation From Baseline to End of Treatment   [ Time Frame: Baseline, End of Treatment (Week 6) ]

28.  Other Pre-specified:   Ability to Reach Toilet at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

29.  Other Pre-specified:   When is Patient Anxious at End of Treatment?   [ Time Frame: End of Treatment (Week 6) ]

30.  Other Pre-specified:   Depression Screening at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

31.  Other Pre-specified:   Patient's Living Situation at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]

32.  Other Pre-specified:   Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment   [ Time Frame: End of Treatment (Week 6) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William E. Whitehead, PhD, Professor of Medicine
Organization: University of North Carolina at Chapel Hill
phone: (919) 843-6961
e-mail: William_Whitehead@med.unc.edu



Responsible Party: William (Bill) Whitehead, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01717456     History of Changes
Other Study ID Numbers: 11-1569
R01HS018695 ( U.S. AHRQ Grant/Contract )
First Submitted: September 15, 2012
First Posted: October 30, 2012
Results First Submitted: May 16, 2016
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017